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Removing the Planning Tumor Volume From Radiation Therapy for the Treatment of Head and Neck Squamous Cell Carcinoma

3 novembre 2026 mis à jour par: City of Hope Medical Center

Pilot Study of the Elimination of Planning Tumor Volume (PTV) in Head and Neck Squamous Cell Carcinoma (HNSCC)

This clinical trial studies the side effects and how well removing the planning tumor volume (PTV) from radiation therapy (RT) works in treating patients with head and neck squamous cell carcinoma (HNSCC). Standard therapy for HNSCC often involves giving RT with chemotherapy; however, this approach is associated with a high level of short- and long-term side effects. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. RT is planned to be delivered based on three volumes of the tumor. The first is the gross tumor volume which is the area of the tumor that can be seen, felt, or measured on imaging. The second is the clinical tumor volume which includes the gross tumor volume as well as area beyond this to account for disease that cannot be seen on imaging and may have spread. The third is the PTV which includes an area beyond both the gross tumor volume and clinical tumor volume to account for errors that may happen during RT, such as setup error or movement. As the area between the clinical tumor volume and PTV is not cancer and current advances in RT have improved RT accuracy, researchers think that removing PTV from RT may lower side effects while still being an effective treatment. Removing the PTV from RT may safe, tolerable, and/or effective in treating patients with HNSCC.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVES:

I. Describe the effect of eliminating PTV on locoregional control and marginal recurrence at 6 months in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

II. Describe the effect of PTV on early toxicity, PRO (patient reported outcomes) and QOL (quality of life) in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

SECONDARY OBJECTIVES:

I. Describe the effect of eliminating PTV on locoregional control at 2 and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

II. Describe the patterns of failure when eliminating PTV at 3 months, 2 years and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

III. Describe the effect of eliminating PTV on later toxicity in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

IV. Describe the effect of eliminating PTV on later PRO (patient reported outcomes) and QOL (quality of life) in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

V. Describe differences in dosimetric comparison plans with and without PTV in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

VI. Describe the effect of eliminating PTV on marginal recurrence rate at 2 and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

OUTLINE:

Patients undergo intensity-modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) without PTV 5-6 times a week for thirty-five treatment fractions over 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent chemotherapy on study. Additionally, patients undergo computed tomography (CT), fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT, and laryngopharyngoscopy during screening and CT or FDG-PET/CT during follow up.

After completion of study treatment, patients are followed up every 3 months during years 1-2 and then every 6 months during years 3-5.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Duarte, California, États-Unis, 91010
        • City of Hope Medical Center
        • Chercheur principal:
          • Arya Amini
        • Contact:
          • Arya Amini
          • Numéro de téléphone: 626-218-2247
          • E-mail: aamini@coh.org

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Documented informed consent of the participant and/or Legally Authorized Representative

    • Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines

  • Age: ≥ 18 years

  • Eastern Cooperative Oncology Group (ECOG) ≤ 2

  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), larynx and hypopharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)

  • No metastatic disease and eligible for definitive radiation based on the following diagnostic workup:

    • General history and physical examination within 56 days prior to registration
    • Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration
    • FDG -PET/CT (with or without contrast) within 60 days prior to registration
    • Diagnostic CT scan of neck (with contrast and of diagnostic quality) within 60 days prior to registration

  • Planning to undergo definitive radiation (with or without chemotherapy)

  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy

    • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Exclusion Criteria:

  • Recurrent disease

  • T1-T2 glottic cancers

  • Definitive clinical or radiologic evidence of metastatic diseases

  • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas

  • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. Patients with unknown primary or resected primary are eligible if gross nodal disease is present

  • Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers

  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

  • Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy

  • Severe, active co-morbidity defined as follows:

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients

    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Hepatitis B testing is not required for entry into this protocol

      • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)

    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment for the hepatitis, they are eligible if they have an undetectable HCV viral load. Hepatitis C testing is not required for entry into this protocol

      • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy

  • Clinically significant uncontrolled illness

  • Females only: Pregnant or breastfeeding

  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treatment (RT without PTV)

Patients undergo IMRT or IGRT without PTV 5-6 times a week for thirty-five treatment fractions over 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent chemotherapy on study. Additionally, patients undergo CT, FDG-PET/CT, and laryngopharyngoscopy during screening and CT or FDG-PET/CT during follow up.
Autre: Survey Administration

Ancillary studies

Médicament: Chemotherapy

Given concurrent chemotherapy

Autres noms:
  • Chimio
  • Chimiothérapie (NOS)
  • Chimiothérapie, Cancer, Général
Procédure: Computed Tomography

Undergo CT and/or FDG-PET/CT

Autres noms:
  • TDM
  • CHAT
  • Scanner
  • Tomographie axiale informatisée
  • Tomographie assistée par ordinateur
  • Tomodensitométrie
  • tomographie
  • Tomographie axiale informatisée (procédure)
  • Tomodensitométrie (TDM)
  • Scan de chat diagnostique
  • Type de service de scan de chat diagnostique
Procédure: Endoscopic Procedure

Undergo laryngopharyngoscopy

Autres noms:
  • ES
  • Endoscopie
  • Examen endoscopique
Procédure: FDG-Positron Emission Tomography and Computed Tomography Scan

Undergo FDG-PET/CT

Autres noms:
  • FDG TEP/TDM
Radiation: Image Guided Radiation Therapy

Undergo IGRT without PTV

Autres noms:
  • IGRT
  • radiothérapie guidée par l'image
  • Radiothérapie guidée par l'image
  • Radiothérapie guidée par image
Radiation: Intensity-Modulated Radiation Therapy

Undergo IMRT without PTV

Autres noms:
  • IMRT
  • RT modulée en intensité
  • Radiothérapie avec modulation d'intensité
  • Radiothérapie, radiothérapie avec modulation d'intensité
  • Radiothérapie avec modulation d'intensité (procédure)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent of patients experiencing locoregional recurrence and marginal recurrence
Délai: At 6 months post-radiation therapy

Will be summarized using descriptive statistics. Will be calculated using the number of patients local or regional recurrence and marginal recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to locoregional recurrence will be measured from completion of radiation therapy to the first documented local or regional recurrence. The cumulative incidence of locoregional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of locoregional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.
At 6 months post-radiation therapy
Incidence of treatment-related adverse events
Délai: From start of treatment to three months post-radiation therapy

As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution.
From start of treatment to three months post-radiation therapy
Change in Functional Assessment of Cancer Therapy Head and Neck Questionnaire (FACT-H&N) v4.0 scores
Délai: From baseline to end of treatment and 3 months post-radiation therapy

At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.
From baseline to end of treatment and 3 months post-radiation therapy
Change in Eastern Cooperative Oncology Group (ECOG) performance status
Délai: From baseline to end of treatment and 3 months post-radiation therapy

At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.
From baseline to end of treatment and 3 months post-radiation therapy

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Locoregional recurrence rate
Délai: At 2 and 5 years post-radiation therapy

Will be summarized using descriptive statistics. Will be calculated using the number of patients local or regional recurrence and marginal recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to locoregional recurrence will be measured from completion of radiation therapy to the first documented local or regional recurrence. The cumulative incidence of locoregional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of locoregional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.
At 2 and 5 years post-radiation therapy
Local recurrence rates
Délai: At 3 months, 2 years, and 5 years post-radiation therapy

Will be summarized using descriptive statistics. Will be calculated using the number of patients local recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to local recurrence will be measured from completion of radiation therapy to the first documented local recurrence. The cumulative incidence of local recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of local recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.
At 3 months, 2 years, and 5 years post-radiation therapy
Regional recurrence rates
Délai: At 3 months, 2 years, and 5 years post-radiation therapy

Will be summarized using descriptive statistics. Will be calculated using the number of patients regional recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to regional recurrence will be measured from completion of radiation therapy to the first documented regional recurrence. The cumulative incidence of regional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of regional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.
At 3 months, 2 years, and 5 years post-radiation therapy
Incidence of treatment-related adverse events
Délai: From start of treatment to 1 year post-radiation therapy

As assessed by CTCAE v6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution.
From start of treatment to 1 year post-radiation therapy
Change in FACT-H&N v4.0 scores
Délai: From baseline to 6, 9, and 12 months post-radiation therapy

At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.
From baseline to 6, 9, and 12 months post-radiation therapy
Change in ECOG performance status
Délai: From baseline to 6, 9, and 12 months post-radiation therapy

At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.
From baseline to 6, 9, and 12 months post-radiation therapy
Prespecified dosimetric parameters for organs at risk
Délai: At time of radiation therapy (Up to 6-7 weeks)

Will be summarized separately for the delivered plan without planning tumor volume (PTV) and the comparison plan generated using PTV. Because both plans are generated for the same patient, the dosimetric quantity will be the within-patient difference between plans. Any formal paired comparisons will be considered exploratory.
At time of radiation therapy (Up to 6-7 weeks)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

City of Hope Medical Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Arya Amini, City of Hope Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

22 juin 2027

Achèvement primaire (Estimé)

22 décembre 2028

Achèvement de l'étude (Estimé)

22 décembre 2028

Dates d'inscription aux études

Première soumission

3 novembre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

9 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25155
  • P30CA033572 (Subvention/contrat des NIH des États-Unis)
  • NCI-2026-07861 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • 25155 (Autre identifiant: City of Hope Medical Center)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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